CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

Carestream DRX-Revolution Mobile X-ray System recalled

Carestream Health is recalling Carestream DRX-Revolution Mobile X-ray System, distributed nationwide in the US. The recall was initiated on 6 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490

Quantity recalled180 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0126-2014
FDA event ID: 65469
Recalling firm: Carestream Health, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2013
FDA classified: 31 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

6 Jun 2013	Recall initiated by company
31 Oct 2013	Classified by FDA	+147 days
6 Nov 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

Product as listed by the FDA

Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

Where it was distributed

Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.

Nationwide Alabama Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Michigan Minnesota North Carolina New Jersey New York Ohio Oklahoma Pennsylvania

Questions about this recall

Is Carestream DRX-Revolution Mobile X-ray System recalled?

Yes. Carestream Health recalled Carestream DRX-Revolution Mobile X-ray System on 6 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-0126-2014.

Why was it recalled?

Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

Which lots are affected?

Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490

Where was it sold?

Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Carestream Health

All 86

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	DRX Revolution Mobile X-Ray System recalled by Carestream Health	Carestream Health	Device Malfunction	Nationwide
15 Nov 2023Device	CLASS II	The DRX-Revolution Mobile X-Ray System is a diagnostic recalled	Carestream Health	Lead & Heavy Metals	Nationwide
8 Mar 2023Device	CLASS II	Drx-Compass/Dr-fit X-ray Systems with Firmware recalled	Carestream Health	Other	Nationwide
22 Jan 2020Device	CLASS II	Kodak DirectView DR3000/3500 recalled by Carestream Health	Carestream Health	Lead & Heavy Metals	IA
1 May 2019Device	CLASS II	OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled	Carestream Health	Other	Nationwide

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